MAUDE Adverse Event Report: ARTHREX, INC. SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS; ACCESSORIES, ARTHROSCOPIC

Model Number SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 01/24/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.It was reported that the risk manager is not releasing the device for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that seven months post-op, the patient reported pain in his knee; an x-ray shows that the tip of the ar-3371-4000 sheath body was in the patient.The original date of the knee scope surgery was (b)(6) 2018.There will be a follow up surgery to remove the tip on (b)(6) 2019.Additional information obtained (b)(6) 2019: the second surgery to remove the un-retrieved fragment was performed on (b)(6) 2019.It was performed at the same facility by the same surgeon.There was no notation made at the time of the original procedure that a piece was missing from the scope sheath used during the procedure.At time of x-ray, when the fragment was discovered, it was the surgeon who determined that the fragment was a piece of the ar-3371-4000 scope sheath.At this time the risk manager will not release the scope sheath or explanted fragment for evaluation by arthrex.

Manufacturer Narrative

Complaint confirmed, the tip was found to have detached from the shaft.The most likely cause is damage from unauthorized repair.

Manufacturer Narrative

Complaint confirmed, the tip was found to have detached from the shaft.Evaluation reveals the tip broke off where its wall thickness is the thinnest, distal to the weld.A likely cause is attempts at straightening the tip after the fenestration area was deformed and damaged.

Event Description

It was reported that seven months post-op, the patient reported pain in his knee; an x-ray shows that the tip of the ar-3371-4000 sheath body was in the patient.The original date of the knee scope surgery was (b)(6) 2018.There will be a follow up surgery to remove the tip on (b)(6) 2019.Additional information obtained 2/4/19: the second surgery to remove the un-retrieved fragment was performed on (b)(6) 2019.It was performed at the same facility by the same surgeon.There was no notation made at the time of the original procedure that a piece was missing from the scope sheath used during the procedure.At time of x-ray, when the fragment was discovered, it was the surgeon who determined that the fragment was a piece of the ar-3371-4000 scope sheath.At this time the risk manager will not release the scope sheath or explanted fragment for evaluation by arthrex.Additional information obtained 3/6/19: facility has released the device which has been returned to arthrex for evaluation.Facility has confirmed that the device and the tip fragment (that was retrieved during the second surgery) were returned in the same package.Upon arrival for evaluation the device tip was not found within the package.Pictures were provided to arthrex by the facility.

• Brand Name: SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
• Type of Device: ACCESSORIES, ARTHROSCOPIC
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8350761
• MDR Text Key: 136516741
• Report Number: 1220246-2019-00913
• Device Sequence Number: 1
• Product Code: NBH
• UDI-Device Identifier: 00888867030145
• UDI-Public: 00888867030145
• Combination Product (y/n): N
• PMA/PMN Number: K080560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SHEATH BODY, TAP/FEN, HF/4MM SCP STH SYS
• Device Catalogue Number: AR-3371-4000
• Device Lot Number: 1307212
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/19/2019
• Supplement Dates Manufacturer Received: 01/24/2019; 01/24/2019
• Supplement Dates FDA Received: 04/24/2019; 06/06/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other